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MAQUET CARDIOPULMONARY GMBH.

Germany · Rastatt

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 1Class II 10Class III 0

plus 24 registration records and 45 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class II 7

21 including historic records

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

40active device licences

Class II 24Class III 7Class IV 9

77 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

11device registrations

CLASS B 3CLASS C 3CLASS D 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

28active ARTG entries

Class I 2Class III 5IIa 12IIb 9

HKHong KongMDACS

7valid listings

Class II 2Class III 2Class IV 3

ILIsraelAMAR

14registrations

RURussiaRoszdravnadzor

18active registrations

Class 2a 2Class 2b 5Class 3 11

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States24 registration records, 45 510(k), 0 PMA, 4 excluded

Brazil7 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada40 confirmed, 3 excluded

Manufacturer names merged into this page: MAQUET CARDIOPULMONARY GmbH · MAQUET CARDIOPULMONARY MEDIKAL TEKNIK SAN. TIC.LTD. STI. · MAQUET CARDIOPULMONARY GMBH · MAQUET CARDIOPULMONARY GMBH. · Maquet Cardiopulmonary GmbH

FDA 510(k) clearances by year

12005

52006

12007

72008

122009

22010

62011

72013

32014

12015

FDA listed device types

showing 8 of 11

Heat-Exchanger, Cardiopulmonary Bypass 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 1Filter, Blood, Cardiopulmonary Bypass, Arterial Line 1Flowmeter, Blood, Cardiovascular 1Console, Heart-Lung Machine, Cardiopulmonary Bypass 1Dilator, Vessel, For Percutaneous Catheterization 1Ventilator, Continuous, Facility Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150267	QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators	2015-05-07
US	K140569	ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)	2014-11-19
US	K141432	NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH	2014-07-07
BR	80259119025	Oxigenador de Membrana Quadrox-i Pediátrico com Filtro Arterial e Rese	Class II
BR	80259110207	Oxigenador de Membrana Quadrox-i Neonatal com Filtro Arterial e Reserv	Class II
BR	80259110209	MAQUET QUADROX-I COM FILTRO COM RESERVATÓRIO VENOSO E CARDIOTOMIA VHK	Class II
SA	ME0000006631SFDAA00151	CARDIOHELP Emergency Drive	—
SA	ME0000006631SFDAA00165	Sprinter Cart	—
CA	20784	CARDIOTOMY BLOOD RESERVOIR	Class II
CA	20785	ARTERIAL CANNULAE - CURVED TIP	Class II
CA	20786	AORTIC ROOT CANNULA	Class II